SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02473211

Enrollment

106

Registered

2015-06-16

Start date

2015-01-31

Completion date

2018-03-15

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Brief summary

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

Detailed description

Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).

Interventions

DRUGSofosbuvir

Sofosbuvir 400 mg tablet administered once daily

DRUGDaclatasvir

Daclatasvir 60mg tablet administered once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients chronically infected with HCV Genotype-1b; 2. Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin; 3. HCV RNA level greater than 10,000 IU/ml at screening; 4. Patients with compensated cirrhosis are permitted.

Exclusion criteria

1. Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded; 2. Screening ECG with clinically significant abnormalities; 3. Laboratory results outside of acceptable ranges at screening; 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Design outcomes

Primary

Measure	Time frame	Description
Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)	Post treatment Week 12	SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026